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Based on observation, interview, and document review, the hospital failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving care in the hospital as evidenced by the facility failure to:

1. Provide active surveillance to identify policies and procedures that are not implemented correctly in an active infection control program. See A-0748

2. Ensure sanitary condition of the Operating Room Suites environment. see A-0748
a. Failed to provide effective monitoring to ensure staff was trained and competent to effectively sterilize hinged surgical instruments, see A- 0749
b. Failed to provide for and monitor material covering operating room equipment, (i.e. patient gurney, arm board ;) which failed to maintained in a condition that would permit the equipment to be disinfected. See-0A749

3. Ensure the sterile surgical instruments and sterile supplies see A-0749
a. Failed to provide effective monitoring of sterile supplies and sterile surgical Instrument storage room. See A-0749
b. Failed to ensure sterile supplies were maintained in accordance with facility policy regarding event-related sterility standard A-0749 and A-0748

4. Integrate active hospital-wide infection prevention and control program into the facility QAPI program. See A-0748
The cumulative effects of these systemic problems resulted in the hospital inability to provide an effective hospital wide infection control program; care in a safe and effective manner in accordance with the Condition of Participation for Infection Control Services.

Based on interview and document review, the hospital failed to ensure that only providers with documented competency to administer general anesthesia were able to administer intravenous propofol (trade name Diprivan®) to patients. This resulted in the potential for physicians without this competency to administer the drug, risking respiratory problems for which the practitioner has not demonstrated the ability to handle.

Findings:

1. Propofol (Diprivan®) is an intravenous medication used for sedation. It has a tendency to easily lead to deep sedation or full anesthesia with the need to perform airway rescue (putting a tube into the lungs and providing mechanical ventilation).

2. The policy entitled Moderate Sedation was reviewed on 4/22/14. Moderate Sedation is defined as "a drug-induced depression of consciousness during which patients respond purposefully to verbal commands ..." "No interventions are required to maintain a patent airway ... " It also states "Qualified non-Anesthesia providers may provide moderate sedation. Deep sedation may be provided by qualified Anesthesia and non-Anesthesia providers with evidence of competence who are qualified by education, certification ... " and "Due to the likelihood of Propofol ...inducing a deep sedation, these medications will be administered by an LIP (licensed independent practicioner) ... " The policy therefore allows for any qualified LIP to administer propofol, which is considered deep sedation, but does not require the provider to present evidence of the ability to deal with the possibility of progression of moderate sedation to deep sedation.

3. The Medical Director of Emergency Services was interviewed on 4/22/14 at 11:30 A.M. He stated that in practice, the only providers using propofol for sedation were anesthesiologists, certified nurse anesthetists and Emergency physicians, all which have the ability to rescue a patient from over sedation with propofol. However, he agreed that the policy and credentialing process did not restrict other providers from seeking these privileges.

4. The Medical Director of Anesthesia was interviewed 4/23/14 at 4:15 P.M. He stated that he had been one of the authors of the Sedation Policy and that the intent was to allow Anesthesiology providers and Emergency Department (ED) doctors to obtain privileges for the use of Propofol in sedation.

5. The minutes of the Credentialing Committee were reviewed 4/22/14 at 2:55 P.M. Three providers were granted "deep" sedation privileges. Their specialties were Internal Medicine, Gastroenterology (GI) and Cardiology. They had documentation of passing a sedation post-test, but no other evidence of training or experience in airway management. Further interviews of the Director of the GI lab and the Director of Medical Staff Services indicated that these physicians were only performing sedation with standard moderate sedation medications but not propofol. However, in the sedation policy their privileges for deep sedation would allow them to administer propofol.

Based on observation, interview and document review, the Hospital's Quality Assurance Program did not include complete monitoring of the effectiveness and safety of services and quality of care in the areas of Infection Control and Surgical Services as well as patient sedation. These include issues with instrument processing and environmental issues in the operating room (OR). This resulted in important information regarding these issues not reaching the Quality Council. Also, the Quality Council was not aware of issues with credentialing of providers for the provision of sedation as regards to the use of propofol. This resulted in the potential for providers without the skills and education to administer or handle complication of deep sedation being granted these privileges.


Findings:

1. The policy entitled Moderate Sedation was reviewed on 4/22/14. Moderate Sedation is defined as "a drug-induced depression of consciousness during which patients respond purposefully to verbal commands ... No interventions are required to maintain a patent airway ..." It also states "Qualified non-Anesthesia providers may provide moderate sedation. Deep sedation may be provided by qualified Anesthesia and non-Anesthesia providers with evidence of competence who are qualified by education, certification ..." and "Due to the likelihood of Propofol ...inducing a deep sedation, these medications will be administered by an LIP (licensed independent practitioner) ..." The policy therefore allows for any qualified LIP to administer propofol, which is considered deep sedation, but does not require the provider to present evidence of the ability to deal with the possibility of progression of moderate sedation to deep sedation.

2. The Medical Director of Emergency Services was interviewed on 4/22/14 at 11:30 A.M. He stated that in practice, the only providers using propofol for sedation were anesthesiologists, certified nurse anesthetists and Emergency physicians, all which have the ability to rescue a patient from over sedation with propofol. However, he agreed that the policy and credentialing process did not restrict other providers from seeking these privileges.

3. The Medical Director of Anesthesia was interviewed 4/23/14 at 4:15 P.M. He stated that he had been one of the authors of the Sedation Policy and that the intent was to allow Anesthesiology providers and ED doctors to obtain privileges for the use of Propofol in sedation.

4. The minutes of the Credentialing Committee were reviewed 4/22/14 at 2:55 P.M. Three providers were granted "deep" sedation privileges. Their specialties were Internal Medicine, Gastroenterology (GI) and Cardiology. They had documentation of passing a sedation post-test, but no other evidence of training or experience in airway management. Further interviews of the Director of the GI lab and the Director of Medical Staff Services indicated that these physicians were only performing sedation with standard moderate sedation medications but not propofol. However, in the sedation policy their privileges for deep sedation would allow them to administer propofol.

5. The sterile processing area was toured 4/23/14 at 10 A.M. In the instrument assembly area, the ceiling was tiled in acoustic tile. There was extensive cracking and breakage of the tiles with exposure of large areas of the cardboard-like material in the middle of the tiles. Flakes of the white coating of the tiles were hanging loosely. The Director of the OR was unaware of this finding.

6. Several ready-to-use instrument trays were opened and inspected during the tour. One Lap Chole (Laparoscopic Cholecystectomy: gall bladder removal using a scope procedure) and one long intruments tray were among the trays inspected. In these trays, clamps and scissors were closed in the trays, making it difficult to ensure that they were adequately sterilized. In some trays the instruments were piled or stacked on top of each other instead of in a single layer as recommended by AORN (Association of periOperative Registered Nurses).

7. AORN recommendations for sterilization of hinged instruments state, All hinged instruments should be sterilized in the open position .... If hinged instruments are on stringers, racks, or instrument pegs, the instruments should be kept open and unlocked. The rationale behind the practice is to expose all surfaces to the sterilant" Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2013:485-504.

Based on interview and document review, the hospital failed to ensure that only providers with documented competency to administer general anesthesia were able to administer intravenous propofol (trade name Diprivan®) to patients. This resulted in the potential for physicians without this competency to administer the drug, risking respiratory problems for which the practitioner has not demonstrated the ability to handle.

Findings:

1. Propofol (Diprovan®) is an intravenous medication used for sedation. It has a tendency to easily lead to deep sedation or full anesthesia with the need to perform airway rescue (putting a tube into the lungs and providing mechanical ventilation).

2. The policy entitled Moderate Sedation was reviewed on 4/22/14. Moderate Sedation is defined as "a drug-induced depression of consciousness during which patients respond purposefully to verbal commands ..." No interventions are required to maintain a patent airway ..." It also states "Qualified non-Anesthesia providers may provide moderate sedation. Deep sedation may be provided by qualified Anesthesia and non-Anesthesia providers with evidence of competence who are qualified by education, certification ... " and "Due to the likelihood of Propofol ...inducing a deep sedation, these medications will be administered by an LIP (licensed independent practicioner) ..." The policy therefore allows for any qualified LIP to administer propofol, which is considered deep sedation, but does not require the provider to present evidence of the ability to deal with the possibility of progression of moderate sedation to deep sedation.

3. The Medical Director of Emergency Services was interviewed on 4/22/14 at 11:30 A.M. He stated that in practice, the only providers using propofol for sedation were anesthesiologists, certified nurse anesthetists and Emergency physicians, all which have the ability to rescue a patient from over sedation with propofol. However, he agreed that the policy and credentialing process did not restrict other providers from seeking these privileges.

4. The Medical Director of Anesthesia was interviewed 4/23/14 at 4:15 P.M. He stated that he had been one of the authors of the Sedation Policy and that the intent was to allow Anesthesiology providers and ED doctors to obtain privileges for the use of Propofol in sedation.

5. The minutes of the Credentialing Committee were reviewed were reviewed 4/22/14 at 2:55 P.M. Three providers were granted "deep" sedation privileges. Their specialties were Internal Medicine, Gastroenterology (GI) and Cardiology. They had documentation of passing a sedation post-test, but no other evidence of training or experience in airway management. Further interviews of the Director of the GI lab and the Director of Medical Staff Services indicated that these physicians were only performing sedation with standard moderate sedation medications but not propofol.

Based on observation, interview and record review, the facility failed to ensure that nursing care plans were developed for 2 of 32 sampled patients related to shortness of breath (1) and high fall risk status (3). As a result, individualized plans of care that addressed the needs of the patients were not available for review by the facility's multidisciplinary team members.


Findings:


1. The facility admitted Patient 1 on 4/19/14 for diagnoses which included congestive heart failure (a disease of the heart that can cause symptoms of shortness of breath) and hypoxemia (an abnormally low level of oxygen in the blood), according to the face sheet. Per the History and Physical (H&P) dated 4/19/14, Patient 1 also had a history of chronic obstructive pulmonary disease (a type of obstructive lung disease characterized by chronically poor airflow) and lung cancer.


When interviewed on 4/22/14 at 10:12 A.M., RN 1 stated that Patient 1's main complaint since admission was "shortness of breath." The RN also stated that the patient received a dose of Lasix® (furosemide - a drug used to clear excess fluid from the body) the morning of 4/22/14. During joint review of the electronic medical record (EMR) with the RN at 10:17 A.M., there was no nursing plan of care to address the patient's shortness of breath.


Review of the facility's policy and procedure (P&P), entitled Plan of Care, Multi-Disciplinary, dated 1/14, directed nursing staff to "initiate the nursing care plan based on data collected during the admission nursing assessment." The P&P also directed nursing staff to "Update, re-evaluate care plan daily by adding/deleting interventions, modifying goal statements, and documenting progress in the electronic medical record."


When jointly interviewed on 4/22/14 at 10:24 A.M., RN 1 and Unit Director 1 both stated that a nursing care plan to address the patient's respiratory status should have been initiated the day the patient was admitted.



2. The facility admitted Patient 3 on 4/20/14 for a diagnosis of left ankle fracture, according to the face sheet. Per the H&P dated 4/20/14, Patient 3 also had a history of peripheral neuropathy (damage to the nerves in toes and fingers which may cause decreased or abnormal sensation.)


When interviewed on 4/22/14 at 2:02 P.M., RN 2 stated that Patient 3 was at high risk for falling and that on admission, the patient was assessed to have a Morse Fall Risk Scale (MFRS - a method of assessing a patient's risk for falling) score of 55. According to RN 2, when a patient had a score greater than 45, the patient was at high risk for falls.


During joint review of the EMR with RN 2 at 2:18 P.M., there was no documentation to indicate a nursing plan of care was initiated to address the patient's high fall risk status.


Review of the facility's P&P, entitled Plan of Care, Multi-Disciplinary, dated 1/14, directed nursing staff to "initiate the nursing care plan based on data collected during the admission nursing assessment." The P&P also directed nursing staff to "Update, re-evaluate care plan daily by adding/deleting interventions, modifying goal statements, and documenting progress in the electronic medical record."


When jointly interviewed on 4/22/14 at 2: 26 P.M., RN 2 and Unit Director 1 both stated that a nursing care plan that addressed the patient's high risk for falls status should have been initiated on the day the facility admitted Patient 3.

Based on observation, interview and record review, the facility failed to ensure nursing staff were labeling intravenous (IV) medications or solutions with the appropriate information prior to administration for 2 of 32 sampled patients (2, 3). As a result, there was a potential for administering the incorrect drug to the incorrect patient.


Findings:


1. The facility admitted Patient 2 on 4/18/14 with a diagnosis of pneumonia (a common lung infection caused by bacteria, a virus or fungi), per the face sheet.

According to the Emergency Department Holding Orders dated 4/18/14, the physician ordered Levaquin® (an antibiotic medication) 750 mg (milligrams) IV to be given daily.

During an observation on 4/22/14 at 11:20 A.M., an IV bag hung on an IV pump and pole in the patient's room. Printed directly on the IV bag was "150 ml Levaquin® (Levofloxacin in 5% dextrose) injection. For intravenous injection." There were no added labels on the IV bag or on the IV tubing.

When interviewed on 4/22/14 at 11:25 A.M., Registered Nurse 1 (RN 1) stated that IV medication bags and "flush" bags should be labeled with the name of the patient, the time and date the medication was hung and "who" hung the medication.

Per the facility's policy and procedure entitled IV Infusion Therapy: Continuous & Intermittent, dated 12/2013, the policy directed RNs to "label IV solutions with the following information if the solutions were prepared by the RN for immediate administration"...: 1. Patient's name and medical record number, 2. Name of additive and fluid, 3. Dosage, 4. Date and time of preparation, and 5. Signature of RN/IVcertified LVN."

During an interview on 4/22/14 at 3:32 P.M., the Pharmacist stated that although the facility used "barcoding" (an inventory control system that uses barcodes to prevent human errors in the distribution of prescription medications at hospitals), the process for the labeling of IV medications had not changed. The expectation was that the IV bag was labeled with the name and dose of the drug, the patient's name, the date and time the medication was hung, and the name of the nurse that hung the medication.


2. The facility admitted Patient 3 on 4/20/14 for a diagnosis of left ankle fracture, per the face sheet.


According to the Physician's Orders dated 4/21/14, the physician ordered "IV LR (Lactated Ringers-solution for fluid and electrolyte replenishment) at 50 cc's (millileters)/hour" and Kefzol® (cefazolin - an antibiotic), 1 gram IVPB (IV piggyback) every 8 hours times 2 doses. In addition, on 4/22/14, the physician ordered a 4 gram dose of Magnesium Sulfate IV.

During an observation on 4/22/14 at 3:10 P.M., there were 3 different IV bags that hung on Patient 3's IV pump and pole in the patient's room. Printed directly on IV bag 1 was "Lactated Ringers." Printed directly on IV bag 2 was "Cefazolin injection." Printed directly on IV bag 3 was "Magnesium Sulfate." There were no added labels on any of the IV bags.

When interviewed on 4/22/14 at 3:17 P.M., RN 2 stated she was not sure if nursing staff still had to label the IV medications since the facility used a barcode system for the administration of medications. RN 2 stated that "we used to label the IV medications with the patient's name, date, time we hung the medication, and our name."

Per the facility's policy and procedure entitled IV Infusion Therapy: Continuous & Intermittent, dated 12/2013, the policy directed RNs to "label IV solutions with the following information if the solutions were prepared by the RN for immediate administration"...: 1. Patient's name and medical record number, 2. Name of additive and fluid, 3. Dosage, 4. Date and time of preparation, and 5. Signature of RN/IVcertified LVN."

During an interview on 4/22/14 at 3:32 P.M., the Pharmacist stated that although the facility used "barcoding" (an inventory control system that uses barcodes to prevent human errors in the distribution of prescription medications at hospitals), the process for the labeling of IV medications had not changed. The expectation was that the IV bag was labeled with the name and dose of the drug, the patient's name, the date and time the medication was hung, and the name of the nurse that hung the medication.

Based on observation and interview, the hospital did not maintian the sterile processing area in order to ensure an acceptable level of safety and quality. The ceiling over the instrument assembly area in sterile processing was chipped and torn. These areas provided rough or permeable surfaces that might not be properly disinfected using standard procedures. There was also a risk of particles contaminating sterile falling from the ceiling into the instrument trays that were being assembled for sterilization.

Findings:

The sterile processing area was toured during the time in the operating room (OR) suite. In the instrument assembly area, the ceiling was tiled in acoustic tile. There was extensive cracking and breakage of the tiles with exposure of large areas of the cardboard-like material in the middle of the tiles. Flakes of the white coating of the tiles were hanging loosely. The Director of the OR was unaware of this finding.

Based on observation, interview and document review, the hospital failed to provide an effective Infection Control program to ensure an active facility-wide infection control program.

Findings:
1. On 4/22/2014 at 11:15 A.M., a review of Infection Control rounds documentation provided by 20 revealed inconsistent monitoring. Documentation of the preceding 6 months Oct 30th 2013 through April 30th 2014 reviewed.
Logs dated and labeled:
12/13, Lab
12/18/13, Laundry Services
1/9/14 Sterile Processing-GI
2/18/14, Med-Surg unit
4/1/14, Women ' s Center
4/22/14 ICU
A prior interview at 11:00 P.M., 20 indicated the expectation is to provide monthly rounds to all areas. She acknowledged she has not been able to complete the rounds. 20 her time allotted a large portion her time is spent with the new Infection Control Nurse recently hired at the hospitals ' Long Term Care (SNF) facility.




2. An observation on 4/22/2014 at 1:00 P.M., with 20, 2 out of 3 Operating rooms (OR ' s) with scuff marks, discoloration of tiles and pit marks in the tile of the flooring noted. An interview conducted with 20 at 1:40 P.M., 20 acknowledged the discoloration, scuff marks and pit marks in the tile of the flooring. 20 further stated, " I did not have personal prior knowledge of the condition of the floors. " 20 acknowledge the infection control committee did not receive notice of the floor condition.


3. An interview 4/22/2014 at 1:30 P.M., conducted with 20. 20 acknowledged she was currently unable to provide an adequate infection control oversight. 20 indicated the facility would prefer her to conduct her duties on less time. 20 indicated she did not know what process is used to determine adequate time allotted for duties required of her. 20 acknowledge she has informed the facility she cannot conduct an adequate infection control program currently and the complexity of the hospital service provided
20 specified she has a past history of CIC certification that she allowed to lapsed which is inconsistent with AORN standards. She acknowledges she does not have current continuing infection control training. Continuing education and/or training documentation was asked for and not provided at the time of exit.

Based on observation, interview and document review the hospital failed to provide a functional and sanitary environment for the provision of surgical services. The facility failed to provide sterile supplies maintained in accordance with facility policy regarding, event-related sterility standards. The facility failed to ensure re-usable surgical instruments were sterilized and stored in accordance with the Association of PeriOperative Registered Nurse (AORN) Standards. AORN is the National Recognized Standards (NRS) the hospital identified as the standard they followed. Thus, the facility failed to ensure the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals involved in surgical processes.

Findings:
1. On 4/23/2014 at 1:45 P.M. 20, 21A and 21B observed surgical trays packed inconsistent with AORN standards. 21A and 21B indicated they follow AORN standards.
Open and inspected:
A laminectomy tray (instruments used for surgery on the back) also known as a Major Tray ready for transport to the operating room.
Assembled in the tray:
A stringer (typically, approximately a foot long 3 rod type device to assist with the positioning of instruments for sterilizing, this tech utilized two hinged instruments to fashion a type of " stringer " ) On the stringer 20 hinged instruments blades closed and tips touching.
A large handle instrument (approximately 12 inches with each handle approx. ½ inch wide) stacked on top of surgical instruments layered on the bottom of the tray. Additionally, Twenty-three (23) hinged instruments observed packed in a tight group. Sixteen (16) out of Twenty (20) hinged instruments blades closed and tips touching. 10 instruments observed wrapped in a blue towel and stacked on top of each other. Six (6) out of the (10) instruments had reddish color substance on the instruments.

2. In a subsequent observation on 4/23/14 at 2:00 P.M, two smaller trays labeled " Plastics " and identified as a minor tray open by 21B revealed instruments in similar condition to the previous open package with hinged instruments closed and blades touching.

Assembled in tray:
One Large long blade scoop type instrument was hanging over the side of the rigid tray with other 6 other instruments stacked on top. Stacked on top of those instruments were 10 smaller instruments with reddish color substance on them wrapped in a blue towel; with 6 of 10 closed with blades observed touching.
This tray included instruments wrapped in a blue towel with reddish color substance on 7 out of 20 instruments.
Thus, four out of four trays were pack inconsistent with facility policy following the national recognized standards to ensure the sterile instruments.

In an interview, 21A and 21B agreed this is a typical condition of the instruments. 21A, 21B, and 20 acknowledge they were not aware of the facility ' s policy and procedure for packing surgical Instruments for sterilization. Policy and procedures for sterile processing of instruments were requested and not received by exit date.
(AORN) Recommendation IV
Instruments should be kept free of gross soil during surgical procedures.
Blood and body fluids can cause pitting of instruments and, if left to dry, can be difficult to remove. If blood and body fluids are not removed, they can prevent adequate sterilization, which could be an avenue for transmission of other potentially infectious materials.
· IV.a. Instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soil.
Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved.
AORN, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, 2013: Instruments should be inspected for ...corrosion, pitting, burrs, nicks, and cracks ...wear and chipping of ...plated surfaces damage[d] protective surfaces of instruments, contribute to corrosion, impede sterilization surface corrosion damage ...can inhibit sterilization
Spotting, Staining, and Corrosion of Surgical Instruments
Surgical instrument Herbert J. Kaiser, PhD; Patrick Schwab, MBA; Jason F. Tirey, MA. (October 1, 2000). Spotting, Staining, and Corrosion of Surgical Instruments. Infection Control Today.
Retrieved from: spotting, staining, and corrosion are serious problems in many healthcare facilities ... Spotting, staining, and corrosion of surgical instruments can impair their function ... Spotting, staining, and corrosion also interfere with sterilization. Spores can be protected from destruction by the layers of iron oxide (rust). Corrosion can result in a shortened instrument life, which results in increased cost.

Stainless Steel
It is important to remember that stainless steel means stainless steel, not stain-proof steel. All types of stainless steel will eventually become corroded and stained. Also, while a surface of an instrument may look bright and shiny to the naked eye, under microscopic examination the surface is actually very rough. The rough surface allows for entrapment of impurities from soils and water ....Spotting lies loosely on the surface. Staining is integral with the surface. Corrosion penetrates the surface... Stainless steel is indeed reactive, meaning that it will corrode and become stained under certain conditions.
(AORN) Recommendation IV
Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.

· IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces.3 [3: Limited Evidence]
Sterilant contact is necessary for sterilization to be achieved.
· IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer ' s written and validated IFU specifies that disassembly is not required.3 [3: Limited Evidence]
Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.3
· IV.f. Items to be sterilized that have concave or convex surfaces that create potential for water retention should be positioned within packages in a manner that prevents those surfaces from retaining water.3,4 [1: Strong Evidence]
Preventing water retention can help avoid the occurrence of wet packs and sterilization failure.
· IV.g. Towels placed within instrument sets should be lint-free, freshly laundered, and thoroughly rinsed by a health care-accredited laundry facility. [3: Limited Evidence]
Adequate rinsing reduces the risk of leaving chemical residues that could be transferred from the towels to instruments.28 Lint left on sterile instruments may be transferred to the surgical wound and may cause a foreign-body reaction.
· IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position. [3: Limited Evidence]

3. On 4/23/2014 at 3:25 P.M, an interview with 24 she indicated that instruments have been worst then the ones viewed today. When asked if the condition of instruments identified with the discolorations were considered ready for the surgeon, she stated, " We need to do something to replace them. " 24 further acknowledge the facility does not currently have a process for quality assurance surveillance for facility-wide Infection Control program. See A-0748 Item 3


4. On 4/23/2014 at 1:00 P.M., in an interview with 21A, 21B the staff could not verbalize the facility ' s policy for Event-Related Sterility. 21A, 21B indicated they were not sure what quality assurance policy the facility followed to ensure sterile surgical Instruments.



5. On 4/23/2014 at 1:00 P.M. an observation of bins containing stored processed sterile instruments not maintained in a manner consistent with the facility ' s policy titled, " storage of sterile supplies and sterile instruments " was conducted.
In a subsequent interview 21B acknowledge the maintained condition of the supplies were not consistent with hospital policy. 21B stated he is not aware of the term, " Event Related Sterility. " However, in review of the facility ' s policy and procedure 21A, 21B acknowledge the facility followed, " Event Related Sterility " when processing and storing of sterile surgical instruments. 21A further acknowledges the sterile surgical Instruments and the sterile supplies were not maintained consistent with the facility ' s policy.
Observed:
Sample storage bin, measuring approx. 2ft by 1 ft. with twenty-four (24) packages were viewed pushed into the bin space placing pressure on the packages. 20 acknowledged peel packs viewed were creased and crumpled. The packages were stored in mostly horizontal state allowing compression on the packages. 21A agreed he could not ensure the surgical Instruments were sterile, thus is removing them from circulation.


6. On 4/22/2014 at 1:00 P.M In a record review of facility policy and procedure titled " OR cleaning " the policy stated, all environmental services department personnel must follow the surgery department dress code which includes scrubs, shoe covers, and cap " . In a concurrent interview 25 acknowledged, the stains and scuff marks in OR 1,2, and 3 need to be removed to ensure the floor is disinfected. 25 also made the observation that staff may not be following the dress code. She acknowledged, if shoes were covered with shoe covers the operating room floors would not have the rubber scuff marks on the floor. In a subsequent interview 21B and 25 both indicated they informed their respective supervisors 24 and 26, of the issues with the floor. See A-748 item 2

7. During an observation 4/22/2014 at 1:50 P.M., mattress pads were observed to have substance buildup and frayed mattress covers.
Operating Room 1:
Mattress pad found to have a buildup of substance covering the first 1/3 of the mattress pad. In addition, a strip of substance 2 inches wide was observed in the middle of the mattress pad and running in a circular pattern at the bottom of the pad.
Operating room 2:
Mattress found to have sticky substance in the top 1/3 of the mattress with 2 " by 3 to 4 " patches of residue running horizontal across the top of the pad and down the side of the mattress in approximately 3.5 in length.
In a interview with 21A , 21A stated, " this should not be here. " In an interview with 25 at 2:54 P.M., it was confirmed that terminal cleaning was completed the night before and the environmental staff believe the operating room to be ready for surgery. 25 acknowledge the substance should not be left on the mattress pad. 25 indicated she reported to her supervisor the cleaning issues in the operating room. 25 indicated 26 was her supervisor.